TriangleNCT02040142 · OUTCOME
Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Up to 5 years
What was measured
PFS is defined as time from operation date to the first documentation of disease progression or death as a result of any cause, whichever comes first. PFS will be censored at the date of last documented progression-free status for patients who are still progression free, alive or lost to follow-up. Determination of disease progression will be based on: * Radiological (CT ± PET), and/or * Surgical (laparoscopic or open exploration) evidence of recurrent disease. Peritoneal disease progression will be confirmed by cytology or histology revealing cells morphologically consistent with malignant tumor cells
Analysis population: For PFS, 14/51 patients were not evaluable due to either never having completed surgery, not receiving HIPEC, having no evidence of cancer at time of surgery, or death due to HIPEC and no response measurement. As such, 37 patients were evaluable for PFS.
Groups in this outcome
HIPEC + Mitomycin C
HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out. HIPEC Mitomycin C
| Group | Source count |
|---|---|
| HIPEC + Mitomycin C | 37 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HIPEC + Mitomycin C | 11.4 | Not reported | 3 | 60 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3
- upper Limit
- 60
- value
- 11.4
- denoms
- counts
- group Id
- OG000
- value
- 37
- units
- Participants
- description
- PFS is defined as time from operation date to the first documentation of disease progression or death as a result of any cause, whichever comes first. PFS will be censored at the date of last documented progression-free status for patients who are still progression free, alive or lost to follow-up. Determination of disease progression will be based on: * Radiological (CT ± PET), and/or * Surgical (laparoscopic or open exploration) evidence of recurrent disease. Peritoneal disease progression will be confirmed by cytology or histology revealing cells morphologically consistent with malignant tumor cells
- dispersion Type
- Full Range
- groups
- description
- HIPEC + 40mg of Mitomycin C. Mitomycin C, 30 mg, were administered into the inflow line of the perfusion circuit once target temperature was reached. At the 60 minute time point of the perfusion, Mitomycin C, 10 mg, was administered into the inflow line of the perfusion circuit. Once the 90-minute perfusion period had elapsed, the perfusate was drained into the waste reservoir. The peritoneal cavity was rinsed/washed-out. HIPEC Mitomycin C
- id
- OG000
- title
- HIPEC + Mitomycin C
- param Type
- MEDIAN
- population Description
- For PFS, 14/51 patients were not evaluable due to either never having completed surgery, not receiving HIPEC, having no evidence of cancer at time of surgery, or death due to HIPEC and no response measurement. As such, 37 patients were evaluable for PFS.
- reporting Status
- POSTED
- time Frame
- Up to 5 years
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice